Staff Preclinical Scientist

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: R&D Product Development

Job Sub Function: Materials/Biomaterials Science

Job Category: Scientific/Technology

All Job Posting Locations: Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Staff Preclinical Scientist position.

The Staff Preclinical Scientist functions as a key member of the DS Toxicology, Biocompatibility and Preclinical team. This person designs, conducts, and interprets preclinical in vivo studies that provide evidence of device safety, performance, and translational relevance while ensuring ethical animal use and regulatory compliance. In addition, the person will apply technical expertise, ingenuity, business experience, and independent judgment to solve preclinical and biological functional safety and performance problems, and designs and implement strategies and priorities for evaluations and studies across multiple projects or product portfolios. 

You will be responsible for: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Develops preclinical testing strategies to support product development, regulatory submissions, and clinical translation. • Designs in vivo studies that evaluate device safety, functionality, performance, and clinical relevance • Selects appropriate animal models, study endpoints, controls, and evaluation methods based on intended use and regulatory expectations. Ensures study objectives address key product risks, design questions, and performance claims • Acts as study sponsor representative for external CRO and research site activities. • Prepares study protocols, technical justifications, and study documentation. • Oversees study conduct to ensure compliance with applicable regulations, GLP requirements, and animal welfare standards. • Analyzes and interprets study data. • Identifies potential risks, failure modes, and opportunities for design improvement. • Stays current with evolving regulatory guidance and and drives continuous improvement in preclinical methodologies and study designs. • As part of multiple projects, partners with R&D, Clinical, Regulatory Affairs, Biocompatibility, Toxicology, Quality, and Marketing teams. Provides consultative direction as well as technical guidance to meet essential requirements necessary to achieve a high-quality product. • Supports interactions with regulatory authorities by providing scientific rationale and study interpretations. • Manages prioritization and communicates resource needs and updates in project support to the the PMO and Manager. • Identifies and evaluates potential risks and drives proactive resolution with team members, peers, PMO and management. • May oversee and lead the work of a group of people and supervise direct reports/contractors. • Provides guidance and mentorship to junior scientists on the team • Can represent the company in regulatory meetings, conferences, standards committees, or industry consortia • Responsible for communicating business related issues or opportunities to next management level • Responsible for following all company guidelines related to Health, Safety and Environmental practices as applicable. • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Qualifications / Requirements: Education • A Bachelor’s or Master’s degree or PhD in biology, chemistry, toxicology, microbiology, veterinary medicine, or a related scientific discipline.  

Experience and Skills Required: • Training in animal research methodologies, pathology or histopathology. • 5-8 years of experience in medical device, pharmaceutical, CRO, or academic research environments. • Experience designing, executing, and interpreting in vivo studies. • Experience working with external research organizations (CROs) and study sites. • Experience analyzing and interpreting preclinical data and study reports. • Working knowledge of applicable regulatory requirements and guidance for non-clinical studies. • Experience authoring scientific protocols, study reports, technical assessments, and regulatory documentation.

Preferred: • Experience in orthopedic, spine, trauma, sports medicine, or other medical device therapeutic areas

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receiv

Similar jobs

• Senior Clinical Scientist — Abbott · Santa Clara, California, United States | New Brighton, Minnesota, United States
• Sr Clinical Scientist — Irhythmtech · Remote
• Staff Scientist — Vast · Houston, Texas, United States; Long Beach, California, United States
• Staff Scientist — Danaher · Boulder, Colorado, United States
• Staff Scientist — University of Chicago · Remote
• Associate Staff Scientist — UAMS - All · Remote
• Senior Clinical Research Scientist — Omadahealth · Remote
• Reference Clinical Lab Scientist — Stanford Health Care · 3375 Hillview - Clinical - PALO ALTO